Multi-mix infusion bag

ABSTRACT

A multi-mix infusion bag is provided. The multi-mix infusion bag includes a lower portion and an upper portion. The lower portion has a lower chamber and the upper portion includes a plurality of chambers. Each chamber is separated and contains a fluid agent. The multi-mix infusion bag is configured to transfer each fluid agent within each chamber of the upper portion into the lower chamber for mixing. The multi-mix infusion bag may include dispensing devices associated with each chamber, wherein the dispensing devices operate to transfer the fluid agents into the lower chamber for mixing.

CROSS REFERENCE TO RELATED APPLICATION[S]

This application is a Continuation of U.S. patent application entitled“MULTI-MIX INFUSION BAG,” Ser. No. 14/804,071, filed Jul. 20, 2015 whichclaims priority to U.S. Provisional patent application entitled“MULTI-MIX INFUSION BAG,” Ser. No. 62/026,171, filed Jul. 18, 2014, thedisclosure of which is hereby incorporated entirely herein by reference.

BACKGROUND OF THE INVENTION Technical Field

This invention relates generally to an infusion bag and moreparticularly to a multi-mix infusion bag.

State of the Art

The use of infusion bags has been critical in the medical industry.These bags have been the means of delivering many types of fluids topatients, for example for various types of intravenous therapies, suchas, but not limited to, correcting electrolyte imbalances, deliveringmedications, transfusing blood, or replacing fluid to correct conditionssuch as dehydration.

A conventional infusion bag typically contains only one solution.Further, it is not able to prevent issues of improper mixing by anadministrator (such as a medical professional or pharmacy employee) dueto human error. Any mixture of components must also be prepared on site,which results in a risk of contamination. This risk is much greater dueto the various sites (location not being sterile) that the mixture willbe prepared in. A conventional infusion bag also does not assure thequality of its contents, does not minimalize variance of the mixedcontents (the mixer is at times inconsistent), and administration ismore cumbersome because the mixture must be prepared beforeadministering a solution to the patient. These drawbacks make itdifficult to provide a mixture of components in an infusion bag fordelivery to a patient.

Accordingly, there is a need for an improved infusion bag to addressthese drawbacks.

SUMMARY OF EMBODIMENTS OF THE INVENTION

The present invention relates to a multi-mix infusion bag, wherein theinfusion bag has a capability to store multiple components that can belater mixed within the same bag.

An embodiment includes a multi-mix infusion bag comprising a lowerportion and an upper portion. The lower portion may have a lowerchamber. The upper portion may comprise a plurality of chambers, whereineach chamber is separated and contains a fluid agent, and wherein themulti-mix infusion bag is configured to transfer each fluid agent withineach chamber of the upper portion into the lower chamber for mixing.

Another embodiment includes a multi-mix infusion bag comprising aseparate lower portion and an upper portion. The lower portion may havea lower chamber. The upper portion may comprise four chambers, whereineach chamber is separated and contains a fluid agent in a storedcondition, and wherein the multi-mix infusion bag is moveable into adispensing condition, wherein each fluid agent within each chamber ofthe upper portion is transferred into the lower chamber for mixing.

Yet, another embodiment includes a method of using a multi-mix infusionbag. The method may comprise providing a multi-mix infusion bag having aplurality of chambers, wherein each chamber is pre-filled with a fluidagent in a stored condition; activating dispensing devices of themulti-mix infusion bag to move the multi-mix infusion bag into adispensing condition, wherein the fluid agent in each chamber istransferred into a lower chamber; mixing the fluid agents to form amixed fluid; and dispensing the mixed fluid to a patient.

The foregoing and other features and advantages of the present inventionwill be apparent from the following more detailed description of theparticular embodiments of the invention, as illustrated in theaccompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

A more complete understanding of the present invention may be derived byreferring to the detailed description and claims when considered inconnection with the Figures, wherein like reference numbers refer tosimilar items throughout the Figures, the Figures are not necessarilydrawn to scale, and:

FIG. 1 is a front view of a multi-mix infusion bag with agentscompartmentalized;

FIG. 2 is a front view of a multi-mix infusion bag with agents mixedtogether;

FIG. 3 is a side view of a multi-mix infusion bag;

FIG. 4A is side view of a perforating device;

FIG. 4B is a side view of another perforating device;

FIG. 5A is a front view of another multi-mix infusion bag with agentscompartmentalized;

FIG. 5B is front view of another multi-mix infusion bag with agentsmixed together;

FIG. 6A is a perspective view of a multi-mix infusion bag with aseparated upper section and lower section;

FIG. 6B is a perspective view of a multi-mix infusion bag with theseparate upper section and lower section coupled together; and

FIG. 7 is a flow chart of a method of operation of a multi-mix infusionbag.

DETAILED DESCRIPTION OF EMBODIMENTS OF THE INVENTION

As discussed above, embodiments of the present invention relate to amulti-mix infusion bag comprising multiple agents stored separately andmixed within the infusion bag prior to dispensing. Embodiments of theinvention can be sold pre-filled and ready to use; reduces risk of humanerror; reduces risk of contamination; increases ease of administration;simplifies the process of administrating infusions intravenously;protects content from oxidation; assures accurate administration;permits little to no variance between the mixtures; increases thecontents shelf life; and prevents contents from reacting adversely andprematurely.

Referring to the drawings, FIGS. 1 and 3 depicts a multi-mix infusionbag 10 in a stored condition, according to embodiments. The multi-mixinfusion bag 10 comprises an upper portion 11 and a lower portion 13.The lower portion 13 comprises a main chamber 12. The upper portion 11may comprise multiple compartments. For example, as shown, and withoutlimitation, the upper portion 11 may include a first chamber 40, asecond chamber 41, a third chamber 42, a fourth chamber 43, a fifthchamber 44 and a sixth chamber 45. The multi-mix infusion bag 10comprises chamber separating members 17, to separate fluid agents 50,51, 52, 53, 54 and 55, wherein first fluid agent 50 is held within firstchamber 40, second fluid agent 51 is held within second chamber 41,third fluid agent 52 is held within third chamber 42, fourth fluid agent53 is held within fourth chamber 43, fifth fluid agent 54 is held withinfifth chamber 44, and sixth fluid agent 55 is held within sixth chamber45. Additionally, the multi-mix infusion bag 10 may comprise aseparating wall 18. The separating wall 18 separates the upper portion11 from the lower portion 13 of the bag 10. The separating wall 18serves to maintain the fluid agents 50-55 from entering lower chamber12. The maintaining of the fluid agents 50-55 separate keeps the agentsfrom reacting with one another until the appropriate time for the agentsto be mixed. This increases shelf life. The first through sixth chambers40-45 may each hold a predetermined amount of fluid. The separation ofthe fluid agents 50-55 constitutes the stored condition.

Further, within each upper chamber 40-45, the multi-mix infusion bag 10may comprise interior dispensing devices. For example, a firstdispensing device 20 corresponds to the first chamber 40, a seconddispensing device 21 corresponds to the second chamber 41, a thirddispensing device 42 corresponds to the third chamber 22, a fourthdispensing device 23 corresponds to the fourth chamber 43, a fifthdispensing device 24 corresponds to the fifth chamber 44, and a sixthdispensing device 25 corresponds to the sixth chamber 45. Eachdispensing device 20-25 may be a plunger and include a perforatingdevice. The first dispensing device 20 may include a first perforatingdevice 30, the second dispensing device 21 may include a secondperforating device 31, the third dispensing device 22 may include athird perforating device 32, the fourth dispensing device 23 may includea fourth perforating device 33, the fifth dispensing device 24 mayinclude a fifth perforating device 34, and the sixth dispensing device25 may include a sixth perforating device 35. As shown in FIG. 1, thedispensing devices 20-25 are in a stored position, wherein the fluidagents 50-55 are maintained in a separated condition.

The multi-mix infusion bag 10 may further include a dispensing bar 16,wherein the dispensing bar 16 couples the dispensing devices 20-25together such that the dispensing bar 16 may be moved in a directiontoward the lower portion 13 of the bag 10. Moving the dispensing bar 16in the direction toward the lower portion 13 results in simultaneouslyactivating each dispensing device 20-25 and moving each into adispensing position. Accordingly, it should be understood that in someembodiments each dispensing device 20-25 may be activated independently,and in other embodiments, the dispensing devices 20-25 may be activatedsimultaneously.

Referring again to the drawings, FIG. 2 depicts the multi-mix infusionbag 10 in a mixing condition according to embodiments. The dispensingdevices 20-25 are shown in the dispensing position. When in thedispensing position, the dispensing devices 20-25 are each depressedtoward the lower portion 13 of the bag 10.

In the order to dispense the fluid agents 50-55 into the lower portion13 of the bag 10, plungers of each of the dispensing devices 20-25 aredepressed toward the lower portion 13 of the bag 10 so that the point 92of the needles 30-35 pierce the separating wall 18. The plungers may bedepressed individually or may be depressed by applying pressure to thedispensing bar 16 which simultaneously forces all of the plungers into adepressed position. When depressed, the needles 30-35 have each piercedthe separating wall 18. The needles 30-35 may each be a conduit, whereinthe fluid agents 50-55 flow through the needles 30-35 respectively andenter into the lower chamber 12. When within the lower chamber 12, thefluid agents 50-55 are mixed together to form a mixed fluid 70 ready tobe dispensed through outlet 60. Outlet 60 is configured to couple toknown tubing for intravenously dispensing the mixed fluid 70 to apatient. During operation, it may be necessary to mix additionaladditives into the mixed fluid 70. Inlet 62 operates to allow theadditional additives to enter the lower chamber 12 and be mixed with themixed fluid 70. Further, hanger 64 may operate to operatively couple thebag 10 to a hanging device typically used to elevate infusion bags. Insome embodiments, the lower chamber may be a size to hold at least thecombined amount of fluid of the upper chambers.

As can be seen in FIGS. 4A-4B, dispensing devices 20-25 may include aplunger which may be the top portion of the dispensing devices 20-25.The plunger allows the dispensing devices 20-25 to be forced into adepressed or engaged location wherein the dispensing devices 20-25 areactivated, allowing the fluid agents 50-55 to flow into the lowerchamber 12 of the bag 10.

Additionally, dispensing devices 20-25 may include lip portion 90,wherein the lip portion 90 of each dispensing device 20-25 may engagedprojections of a tube engagement with each upper chamber 40-45. The lip90 inhibits removal of dispensing devices 20-25 once they are engagedwithin the tubes of the chambers 40-45.

Additionally, perforating devices 30-35 have various embodiments thatare contemplated, such as, but not limited to a needle, a conduit andthe like. For example each perforating device 30-35 may include a point92 for puncturing the separation wall 18. Each perforating device 30-35may also include a channel 94 wherein once the perforating device 30-35punctures the separation wall 18. Channel 94 creates a fluid channelbetween upper chambers 40-45 and lower chamber 12. Fluid can then flowby gravity from the upper chambers 40-45 to the lower chamber 12. Otherembodiments of needles 30-35 include a point 92 and a conduitperforating device having perforations 96 to allow fluid to enter theconduit portion and flow through an opening at the point 92. Fluid canthem flow by gravity from the upper chambers 40-45 to the lower chamber12. It will be understood that other types of needles may be used solong as a fluid communication between each of the upper chambers 40-45and the lower chamber 12 is formed.

Referring to FIG. 5A another embodiment of a multi-mix infusion bag 110in a stored condition, according to embodiments. The multi-mix infusionbag 110 comprises an upper portion 111 and a lower portion 113. Thelower portion 113 comprises a main chamber 112. The upper portion 111may comprise multiple compartments. For example, as shown, and withoutlimitation, the upper portion 111 may include a first chamber 140, asecond chamber 141, a third chamber 142, a fourth chamber 143, a fifthchamber 144 and a sixth chamber 145. The multi-mix infusion bag 110comprises chamber separating members 117, to separate fluid agents 150,151, 152, 153, 154 and 155, wherein first fluid agent 150 is held withinfirst chamber 140, second fluid agent 151 is held within second chamber141, third fluid agent 152 is held within third chamber 142, fourthfluid agent 153 is held within fourth chamber 143, fifth fluid agent 154is held within fifth chamber 144, and sixth fluid agent 155 is heldwithin sixth chamber 145. Additionally, the multi-mix infusion bag 110may comprise a separating wall 118. The separating wall 118 separatesthe upper portion 111 from the lower portion 113 of the bag 110. Theseparating wall 118 serves to maintain the fluid agents 150-155 fromentering lower chamber 112. The maintaining of the fluid agents 150-155separate keeps the agents from reacting with one another until theappropriate time for the agents to be mixed. This increases shelf life.The first through sixth chambers 140-145 may each hold a predeterminedamount of fluid. The separation of the fluid agents 150-155 constitutesthe stored condition.

FIG. 5B depicts the multi-mix infusion bag 110 in a mixing conditionaccording to embodiments. The upper chambers 140-145 are shown in adispensing position, wherein pressure is applied to each upper chamber140-145 to form a perforation in separating wall 118. When in thedispensing position, the perforations in the separating wall 118 allowfor the fluid agents 150-155 to flow through the perforations and enterinto the lower chamber 112. When within the lower chamber 112, the fluidagents 150-155 are mixed together to form a mixed fluid 170 ready to bedispensed through outlet 160. Outlet 160 is configured to couple toknown tubing for intravenously dispensing the mixed fluid 170 to apatient. During operation, it may be necessary to mix additionaladditives into the mixed fluid 170. Inlet 162 operates to allow theadditional additives to enter the lower chamber 112 and be mixed withthe mixed fluid 170. Further, hanger 164 may operate to operativelycouple the bag 110 to a hanging device typically used to elevateinfusion bags. In some embodiments, the lower chamber 112 may be a sizeto hold at least the combined amount of fluid of the upper chambers140-145.

Referring to FIG. 6A another embodiment of a multi-mix infusion bag 210in a stored condition, according to embodiments. The multi-mix infusionbag 210 comprises an upper portion 211 and a lower portion 213, whereinthe upper portion 211 is separate from the lower portion 213. The lowerportion 213 comprises a main chamber 212. The upper portion 211 maycomprise multiple compartments, wherein the upper portion 211 may becoupled to the lower portion 213 in order to form a complete multi-mixinfusion bag 210. For example, as shown, and without limitation, theupper portion 211 may include a first chamber 240, a second chamber 241,a third chamber 242, and a fourth chamber 243. The multi-mix infusionbag 210 comprises chamber separating members 217, to separate fluidagents held within each upper chamber 240-243. Each upper chamber240-243 comprises an outlet portion 280, through which the separatefluid agents are dispensed.

FIG. 6B depicts the multi-mix infusion bag 210 in a connected conditionaccording to embodiments. The upper portion 211 includes a firstconnecting member 290 and the lower portion 213 includes a secondconnecting member 292. The first connecting member 290 may engaged thesecond connecting member 292 in order to couple the upper portion 211 tothe lower portion 213. In some embodiments, the first connecting member290 may be a tongue with pawls and the second connecting member 292 maybe a groove receiver. It is understood that other connecting devices maybe utilized, so long as the upper portion 211 is coupled to the lowerportion 213. The upper chambers 240-243 are shown with outlet ports 280engaging inlet ports 282 and a separating wall 218 is formed. With theoutlet ports 280 engaging the inlet ports 282, the separated fluidagents may be transferred from the upper chambers 240-243 to the lowerchamber 212 through the outlet ports 280 and inlet ports 282 by meanspreviously described in FIGS. 1-3 and 5A-5B. During operation, it may benecessary to mix additional additives into the mixed fluid 170. Inlet262 operates to allow the additional additives to enter the lowerchamber 212 and be mixed with the mixed fluid 170. Further, hanger 264may operate to operatively couple the bag 210 to a hanging devicetypically used to elevate infusion bags. In some embodiments, each upperchamber 240-243 may hold a predetermined amount of fluid, and the lowerchamber 212 may be a size to hold at least the combined amount of fluidof the upper chambers 240-243.

While it has been shown in FIGS. 1-3 and 5A-5B that the multi-mixinfusion bag comprises six chambers and FIGS. 6A-6B show 4 upperchambers, some embodiments may include two chambers, three chambers,four chambers, five chambers, six chambers, seven chambers, eightchambers or more. It may be contemplated that any number of chambers maybe utilized in a multi-mix infusion bag.

Additionally, the multi-mix infusion bag may be amber in color andtherefore impedes light and oxidation. The bag may be formed of siliconethat is latex free, pvc free and DEHP free.

Referring again to the drawings, FIG. 7 depicts a flow chart showing amethod 80 of using a multi-mix infusion bag according to embodiments.The method 80 may include providing a multi-mix infusion bag having aplurality of chambers, wherein each chamber is pre-filled with a fluidagent (Step 81). The method may then include activating dispensingdevices of the multi-mix infusion bag, wherein the fluid agent in eachchamber is transferred into a lower chamber for mixing (Step 82). Thefluid is then mixed (Step 83). Once the fluid is mixed, the method 80includes dispensing the mixed fluid to a patient.

Step 82 of activating the dispensing devices may include independentlyactivating each dispensing device. In other embodiments, activating thedispensing devices may include simultaneously activating all of thedispensing devices.

The method 80 may further include transferring an additive to the mixedfluid through an inlet of the multi-mix infusion bag. The method mayalso include impeding light and oxidation.

The embodiments and examples set forth herein were presented in order tobest explain the present invention and its practical application and tothereby enable those of ordinary skill in the art to make and use theinvention. However, those of ordinary skill in the art will recognizethat the foregoing description and examples have been presented for thepurposes of illustration and example only. The description as set forthis not intended to be exhaustive or to limit the invention to theprecise form disclosed. Many modifications and variations are possiblein light of the teachings above without departing from the spirit andscope of the forthcoming claims.

1. A multi-mix infusion bag comprising: a lower portion having a lowerchamber; an upper portion comprising a plurality of chambers, whereineach chamber is separated and contains a fluid agent; a separating walllocated between the upper portion and the lower portion to prevent thefluid agents in the plurality of chambers from entering the lowerchamber; and a plurality of perforations formed the separating wall, theplurality of perforations corresponding to the plurality of chambers,wherein each perforation is formed in response to pressure applied toeach of the plurality of chambers of the upper portion, wherein thefluid agent from each of the plurality of chambers is transferred intothe lower chamber through the perforations for mixing of the fluidagents.
 2. The bag of claim 1, further comprising an outlet coupled tothe lower chamber, wherein the mixed fluid agents are dispensed throughthe outlet.
 3. The bag of claim 2, further comprising an inlet coupledto the lower chamber.
 4. The bag of claim 3, wherein an additive isflowed into the lower chamber through the inlet and mixed with the fluidagents in the lower chamber.